AccessGUDID - DEVICE: PERF-GEN Pulsatile Perfusion Solution (13700911900492)

GUDID

Device Identifier (DI) Information

Brand Name: PERF-GEN Pulsatile Perfusion Solution
Version or Model: PERF-GEN/1000/US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INSTITUT GEORGES LOPEZ

Primary DI Number: 13700911900492
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 393146183 *Terms of Use

Device Description: Clear, sterile, non-pyrogenic solution intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
18004	Donor-organ/tissue/cell preservation solution	A solution intended to be used for the flushing, transport, storage and preservation of donor cells, tissues and/or organs (e.g., stem cells, skin, amniotic membrane, cardiovascular tissue, bone, tendon, kidney, liver, heart, pancreas) intended for transplantation. The solution contains a mixture of chemicals/ingredients intended to maintain cell/tissue/organ viability until implantation in the recipient; some types may be combined with blood. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDL	Set, Perfusion, Kidney, Disposable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221386	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 35.6 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c079104f-347c-4323-a3b1-170012f7b034
Public Version Date: December 08, 2022
Public Version Number: 2
DI Record Publish Date: July 27, 2022